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‘Viagra For Women’ Gets FDA Approval: Health Risks, Pricing And Other Details Here

‘Viagra For Women’ Gets FDA Approval: Health Risks, Pricing And Other Details Here
Pfizer Viagra mouse Toshiyuki IMAI / Flickr CC BY-SA 2.0

Health

‘Viagra For Women’ Gets FDA Approval: Health Risks, Pricing And Other Details Here

Addyi, the pill that is most popularly known as the female Viagra, has been approved by the U.S. Food and Drug Administration on August 18.

Addyi, the pill that is most popularly known as the female Viagra, has been approved by the U.S. Food and Drug Administration on August 18. The pill is specifically aimed at treating acquired generalized hypoactive sexual desire disorder or HSDD in premenopausal women, FDA said in its announcement.

However, the approval comes with strong warnings against possible side effects and contraindication of the pill. Additionally, industry experts are saying that the pill will be more costly than its male counterpart. Moreover, the pill may not be covered by health insurance companies.

Addyi increases female libido

HSDD in women is characterized by low sexual desire that causes distress and interpersonal difficulty, the FDA explained in its announcement. The disorder is not due to a co-existing medical or psychiatric condition, problems with the relationship, medication or drug abuse. HSDD is acquired. Hence, it could be treated by a pill such as the Addyi which is the first of its kind.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option. The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER).

Health risk warnings

Addyi, however, cannot be bought over the counter and doctors are advised to be vigilant in prescribing the pill, especially to patients who could not stop from drinking alcohol.

“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies. Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment,” Dr. Woodcock explained further.

Also read: “female Viagra” backed by FDA, Crtics Raised Question

Patients who will drink alcohol even when taking Addyi are warned about experiencing severe low blood pressure and loss of consciousness. Those with liver impairment and those who are taking certain medicines that interfere with the breakdown of Addyi in the body are being strongly advised against taking the pill.

These warnings will come in an approved Boxed Warning to highlight the risks of the severe hypotension and consciousness loss that might be experienced when combining Addyi and alcohol. In addition, the FDA is requiring the company that owns Addyi to conduct three well-designed studies in women to better understand the known serious risks of the interaction between Addyi and alcohol.

A separate announcement from Sprout Pharmaceuticals, the company that developed the pill, said Addyi is not indicated for the treatment of HSDD in postmenopausal women or in men and is not indicated to enhance sexual performance.

Addyi pricing

Cindy Whitehead, the chief executive of Sprout, said the pill will be available starting October 17. She said that its final pricing is yet to be decided. According to a report from The New York Times, Whitehead estimated that the pill will be priced just like the counterpart pill for men. However, unlike Viagra which is taken when needed, Addyi is supposed to be taken nightly before bedtime. This is where a big difference in pricing occurs.

Writing for Forbes, John LaMattina, former head of R&D for Pfizer, the maker of Viagra, estimated that since Addyi is to be taken nightly, its annual cost come close to “$5000/patient.” LaMattina also said that “insurance companies may not be willing to reimburse patients this amount of money.”

LaMattina further stated that Addy “won’t come close to meeting the needs of the female sexual dysfunction population as Viagra and Cialis did for erectile dysfunction.” Hence, “even if payers cover a portion of the cost, as happens with erectile dysfunction drugs, will patients be willing to pay $50 or $75 a month for a drug with Addyi safety/benefit profile?” LaMattina argued.

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About Athena Yenko

Athena is interested about four of the world powers namely U.S., China, Russia and Iran and how they impact the world. She is also interested about the British Monarchy and the ISIS. She had been covering wide variety of issues surrounding nuclear proliferation, military weapons and world crisis. Follow her and be updated about the South China Sea dispute and U.S.-China-Russia close calls or simply whether a new Royal Baby is already on the way.

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